mk-7684a with or without other anticancer therapies in participants with selected solid tumors (mk-7684a-005) (keyvibe-005)

Conditions: Uterine Cervical Neoplasms; Endometrial Neoplasms; Squamous Cell Carcinoma of Head and Neck; Gallbladder Neoplasms; Cholangiocarcinoma; Esophageal Neoplasms; Triple Negative Breast Neoplasms; Hepatocellular Carcinoma; Urinary Bladder Neoplasms; Ovarian Neoplasms; Stomach Neoplasms

Summary: the purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (mk-7684a) with or without other anticancer therapies in participants with selected advanced solid tumors. the primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.


Eligibility criteria:
inclusion criteria: * one of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors: * squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix * endometrial cancer * head and neck squamous cell carcinoma (hnscc) * unresectable biliary adenocarcinoma (gallbladder or biliary tree \[intrahepatic or extrahepatic\] cholangiocarcinoma) * adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic siewert type 1 adenocarcinoma of the gastroesophageal junction (gej). * triple-negative breast cancer (tnbc) * hepatocellular carcinoma (hcc) * urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra * ovarian cancer * gastric cancer * measurable disease per recist v1.1 as assessed by bicr or local site investigator. * adequately controlled blood pressure (bp) with or without antihypertensive medications. * human immunodeficiency virus (hiv)-infected participants must have well controlled hiv on anti-retroviral therapy (art). * male participants must agree to follow contraceptive guidance. * female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (wocbp) or is a wocbp and agrees to follow contraceptive guidance. * adequate organ function. exclusion criteria: * history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. * prior therapy with anti-programmed cell-death (pd-1), anti-pd-l1, anti-pd-l2, or anti-t-cell immunoreceptor with ig and itim domains (tigit) agent. * prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation. * received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. administration of killed vaccines are allowed. * diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication. * active autoimmune disease that has required systemic treatment in past 2 years. * active infection requiring systemic therapy. * concurrent active hepatitis b and hepatitis c virus infection. * history of allogenic tissue/solid organ transplant. * previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm). * has clinically significant cardiovascular disease within 12 months from first dose of study intervention.

Keywords: programmed cell death-1 (pd1, pd-1) programmed death-ligand 1 (pdl1, pd-l1)